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Procedure

Self-Collected Pap Smear for Cervical Cancer Screening (Pap Trial)

N/A
Recruiting
Led By John B Waits, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 14 days
Awards & highlights

Pap Trial Summary

This trial will test whether a self-administered Pap smear is as accurate as one administered by a healthcare provider.

Who is the study for?
This trial is for women aged 21-65 in rural Alabama who are due for routine cervical cancer screening. It's not open to those with a history of cervical cancer, a positive Pap smear result, those who've had their uterus and cervix removed, or anyone in another cancer prevention study.Check my eligibility
What is being tested?
The study is comparing the effectiveness of self-administered Pap smears (Self-PAP) versus traditional Pap smears done by healthcare providers to see if they're equally accurate for cervical cancer screening.See study design
What are the potential side effects?
There are generally no side effects associated with either method of Pap smear testing. However, some individuals may experience mild discomfort or spotting after the procedure.

Pap Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 21-65 needing a routine cervical cancer screening.

Pap Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the self-PAP against the traditional Pap smear procedure

Pap Trial Design

2Treatment groups
Experimental Treatment
Group I: Traditional PapExperimental Treatment1 Intervention
Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the traditional, healthcare provider obtained Papanicolaou (Pap) smear specimen. They will be compared to each other for congruence and accuracy.
Group II: Self-PAPExperimental Treatment1 Intervention
Each patient will participate in both arms of the study on the day of the clinical examination. This arm includes the self-administered Papanicolaou (Pap) smear. They will be compared to each other for congruence and accuracy.

Find a Location

Who is running the clinical trial?

Cahaba Medical Care FoundationOTHER
University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,161 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,635 Total Patients Enrolled

Media Library

Self-PAP (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04093388 — N/A
Cervical Cancer Research Study Groups: Traditional Pap, Self-PAP
Cervical Cancer Clinical Trial 2023: Self-PAP Highlights & Side Effects. Trial Name: NCT04093388 — N/A
Self-PAP (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04093388 — N/A
Cervical Cancer Patient Testimony for trial: Trial Name: NCT04093388 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to join this experimentation?

"Affirmative. The details found on clinicaltrials.gov demonstrate that this trial, which was first listed April 26th 2021, is currently open for enrollment. 250 participants are needed from 3 distinct sites."

Answered by AI

What is the scope of this trial's participant recruitment?

"Affirmative. Clinicaltrials.gov hosts evidence that this investigation, which was initiated on April 26th 2021, is actively enrolling patients at the time of writing. Around 250 people need to be enrolled from 3 distinct sites before completion."

Answered by AI

Does this experiment seek to involve participants aged 45 or over?

"This study has a participant demographic that is limited to those aged 21 and over, with the upper age limit set at 65."

Answered by AI

What criteria must a person meet in order to be accepted into this research endeavor?

"To participate in this research, each patient must be female, between the ages of 21 and 65 years old, possess uterine cervical neoplasms, and comply with national guidelines for routine cervical cancer screening. A total of 250 patients are being accepted."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Cahaba Medical Care - West End
Cahaba Medical Care - Ensley
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I love to help others. Would like to know if a Pap smear can be self administered.
PatientReceived 2+ prior treatments
Recent research and studies
~7 spots leftby Apr 2024